FDA Clears Pfizer's BRAFTOVI® + MEKTOVI® for Lung Cancer with BRAF V600E Mutation

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) fo...

October 13, 2023 | Friday | News
SS Innovations Receives Regulatory Approvals from the Guatemala Ministry of Health

SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic tech...

October 11, 2023 | Wednesday | News
Novo Nordisk Halts Weekly Semaglutide Kidney Trial FLOW Due to Interim Analysis

The decision to stop the trial is based on a recommendation from the independent Data Monitoring Committee (DMC) concluding that the results from an interi...

October 11, 2023 | Wednesday | News
Oxford BioTherapeutics Announces Boehringer Ingelheim's Fast Track Status for Cancer Treatment

BI 764532 is an investigational T-cell engager that redirects T cells towards cancer cells expressing the DLL3 protein DLL3 was discovered using OBT&rsq...

October 04, 2023 | Wednesday | News
FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®

TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United States FDA approval is based on a robust analytical, non...

October 02, 2023 | Monday | News
Everest Medicines Secures Taiwan Approval for XERAVA® in Treating Complicated Intra-Abdominal Infections in Adults

"The NDA approval of XERAVA® in Taiwan marks an important step towards bringing this novel, critical therapy for complicated intra-abdominal infections...

September 28, 2023 | Thursday | News
Industry 4.0 for USP 467: Unlocking Lab Productivity Potential

In today’s evolving industrial landscape, the concept of Industry 4.0 is revolutionizing various sectors by leveraging digitalization and automation ...

September 26, 2023 | Tuesday | News
Alvotech Announces Approval in Japan of AVT04 (ustekinumab), a Biosimilar to Stelara®

“We are thrilled to receive marketing approval for AVT04 in Japan, which will be Alvotech’s second marketed biosimilar,” said Robert Wess...

September 26, 2023 | Tuesday | News
Japan Approves EPKINLYTM as First Bispecific Antibody for R/R LBCL

Subcutaneous EPKINLYTM (epcoritamab) is the first and only bispecific antibody approved in Japan to treat adult patients with certain types of relapsed/r...

September 26, 2023 | Tuesday | News
NeuroSense Granted Patents in Europe, Japan, and Israel for its ALS Drug PrimeC

Patents valid through 2038 Clinical topline results from Phase 2b ALS trial expected in H2 2023 Corresponding patents have b...

September 21, 2023 | Thursday | News
European Commission Approves ORSERDU® for ER+ Breast Cancer with ESR1 Mutation

Each year in Europe more than 550,000 patients are diagnosed with breast cancer, of whom 70% have estrogen receptor (ER)-positive disease¹; more tha...

September 14, 2023 | Thursday | News
10x Wins Injunction From Unified Patent Court Banning Sales of NanoString's CosMx Products in Europe

10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, announced  that the European Unified Patent Court ("UPC") issued a...

September 20, 2023 | Wednesday | News
Baird Medical's Sterile Biopsy Needle Gains Approval from Jiangsu Medical Products Administration in China.

Baird Medical's MWA products have been available in China for many years, and the Company is known as a market leader in MWA technology for thyroid and bre...

September 06, 2023 | Wednesday | News
MedAlliance Enrolls First Patient in SELUTION SLR LOVE-DEB Coronary Study

The aim of the LOVE-DEB Study (Large de-NOVo coronary artEry disease treated with sirolimus Drug Eluting Balloon: prospective evaluation of safety & ef...

September 06, 2023 | Wednesday | News

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